Study on the Legal System of Drug Reevaluation in America，European Union ，Japan and the Enlightenment to China
- VernacularTitle:美国、欧盟、日本药品再评价的法律制度研究及对我国的启示
- Author:
Qi ZHANG
1
;
Jianzhou YAN
1
;
Wen YAO
1
;
Rong SHAO
1
Author Information
1. National Drug Policy and Medical Industry Economy Research Center，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
Drug reevaluation;
Legal system;
America;
European Union;
Japan;
China;
Enlightenment
- From:
China Pharmacy
2019;30(18):2449-2454
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To provide reference for the establishment and improvement of drug reevaluation system in China. METHODS： The design and relevant laws of drug reevaluation system in America， European Union and Japan were reviewed and summarized. The shortcomings of drug evaluation in China were analyzed and suggestions for improvement were put forward. RESULTS & CONCLUSIONS： America， European Union and Japan have formulated relevant laws and systems for post-marketing reappraisal of drugs， as well as specific implementation norms and technical support plans. The legal system of drug reevaluation in America can be divided into ADR monitoring and reporting system， post-marketing drug research system and active drug safety risk monitoring system. The European Union mainly has a monitoring and evaluation system for conventionally marketed drugs， drugs licensed under exceptional circumstances or conditions， and a re-registration system for drugs. Japan’s legal system of reevaluation mainly consists of reexamination system， reevaluation system and other systems. However， there are still some shortcomings in the drug reevaluation in our country， such as weak system， weak legislation， inadequate operability and deterrence， ineffective links between the implementation and application of drug evaluation results， and ineffective allocation of resources. It is suggested that we should integrate the existing reevaluation system to improve the legal system of drug reevaluation in China，starting from the systematic construction of the legal system of drug reevaluation， the construction and standardization of the legislative level， the connection of the legal system of drug reevaluation and the allocation of resources.
